Official Title
A Randomized, Controlled, Phase 2b Study to Evaluate Safety and Efficacy of Rivaroxaban (Xarelto®) for High Risk People With Mild COVID-19
Brief Summary

The purpose of this study is to assess safety and clinical efficacy of rivaroxaban in people with mild Coronavirus Disease 2019 who are at increased risk of disease progression.

Terminated
COVID-19

Drug: Rivaroxaban

Participants self-administered rivaroxaban, 10 milligrams (mg) (1 tablet) orally once daily for 21 days.

Drug: Placebo

Participants self-administered rivaroxaban matching placebo orally once daily for 21 days.

Eligibility Criteria

Inclusion Criteria:

- Participants must be at high-risk for Coronavirus disease 2019 (COVID-19) disease
progression by fulfilling at least one of the following criteria at screening:

- Presence of chronic pulmonary disease, chronic obstructive pulmonary disease
(COPD), pulmonary hypertension

- Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for
treatment

- Hypertension, requiring at least one oral medication for treatment

- Immunocompromised status due to disease (e.g., those living with human
immunodeficiency virus with a cluster of differentiation 4 [CD4] T-cell count of
<200 per cubic millimeter [mm^3])

- Immunocompromised status due to medication (e.g., taking 20 milligram [mg] or
more of prednisone equivalents a day, anti-inflammatory monoclonal antibody
therapies, cancer therapies)

- Any chronic disease that is associated with high risk for severe COVID in the
opinion of the site investigator

- Body mass index ≥35 Kilogram per square meter (kg/m^2) (based on self-reported
weight and height).

- Documented Severe Acute Respiratory Syndrome Coronavirus 2 positive diagnostic test of
≤7 days at the time of screening

- Symptomatic for COVID-19 for ≤72 hours at the time of screening (defined as having at
least 2 of the following symptoms of COVID-19 that is of new onset or has worsened
from baseline, and include fever, chills, myalgia, arthralgia, headache, fatigue,
cough, sore throat, nasal congestion, anosmia, ageusia, nausea, vomiting, or diarrhea.
If only two symptoms are present, they cannot both be anosmia and ageusia)

- Capable of giving informed consent, which includes compliance with the requirements
and restrictions listed in the inform consent form and in this protocol

- Agree to participate in all remote, in-person or home visits as required in the
protocol and provide updated contact information as necessary.

- Female of childbearing potential must agree to practice adequate contraception during
the study

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

- Currently hospitalized or under immediate consideration for hospitalization at
screening and Day 1

- Have new onset shortness of breath or increased shortness of breath from pre-COVID-19
(for people with known COPD) at screening and Day 1

- Hypoxemia (oxygen saturation <94% in ambient air or oxygen saturation below
pre-COVID-19 level for people with known COPD) at Day 1

- Require supplemental oxygen (new requirement or increase in requirement from
pre-COVID-19 condition) at screening and Day 1

- Have a history of (in the past 3 months) or current active pathological bleeding

- Have a history of hemorrhagic stroke or intracranial hemorrhage

- Have a recent severe head trauma within 30 days which includes concussion, skull
fracture or hospitalization for head injury

- Have known intracranial neoplasm, cerebral metastases, arteriovenous malformation or
aneurysm

- Have history of pregnancy-related hemorrhage

- Have active gastroduodenal ulcer or other gastrointestinal bleeding diagnosed in the
past 3 months

- Currently are in a hemodynamically unstable state

- Currently require thrombolysis or pulmonary embolectomy

- Have history of severe hypersensitivity reaction to Xarelto®

- Currently have a prosthetic heart valve

- Have known diagnosis of triple positive antiphospholipid syndrome

- Have known diagnosis of chronic kidney disease (stage IV or receiving dialysis)

- Have a history of thrombocytopenia or known platelet count <100,000 cells/mm^3

- Have history of bronchiectasis and pulmonary cavitation

- Have active cancer (e.g, receiving chemotherapy or treatment for complication of the
active cancer)

- Had epidural or neuraxial anesthesia or spinal puncture in the past 2 weeks and plan
to undergo these procedures during the study

- Had surgery in the past 4 weeks or plan to undergo surgery during the study

- Currently is pregnant or plans to become pregnant

- Currently is breastfeeding

- Share household with an enrolled participant in this study

- Co-enrollment in any clinical trial that includes prohibited procedures (spinal
puncture or surgery) or that includes treatments within the same drug class as
rivaroxaban or treatments for which co-administration with rivaroxaban are prohibited.
Note that any co-enrollment other than this requires approval by the Sponsor. For any
co-enrolled study, the total volume of blood samples collected across the studies
should not exceed 275 milliliters (mL) in 4 weeks.

- Currently using and plan to use the following medications during the study

- Rivaroxaban or drugs in the same class

- Dual anti-platelets therapy

- Other anticoagulants

- Combined Permeability glycoprotein (P-gp) and cytochrome P450 3A (CYP3A)
inhibitors and inducers

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Kingdom
United States
Locations

Woodland Research Northwest LLC - ERG - PPDS
Rogers, Arkansas, United States

Science 37, Inc
Los Angeles, California, United States

Allergy and Asthma Medical Group and Research Center - CRN - PPDS
San Diego, California, United States

Invesclinic, LLC
Fort Lauderdale, Florida, United States

Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, United States

LCC Medical Research - Miami - BTC - PPDS
Miami, Florida, United States

Adult Medicine of Lake County
Mount Dora, Florida, United States

Providea Health Partners LLC
Evergreen Park, Illinois, United States

Clinical Research Institute, Inc - CRN - PPDS
Minneapolis, Minnesota, United States

Encompass Care
North Las Vegas, Nevada, United States

Riverside Medical Group - Circuit- PPDS
Secaucus, New Jersey, United States

NYC Health + Hospitals/Lincoln
Bronx, New York, United States

Elmhurst Hospital Center
Elmhurst, New York, United States

Harlem Hospital Center
New York, New York, United States

Premier Family Physicians - Austin - Hunt - PPDS
Austin, Texas, United States

Village Health Partners - Plano - Hunt - PPDS
Plano, Texas, United States

South Texas Allergy and Asthma Medical Professionals
San Antonio, Texas, United States

Boundary House Medical Centre
Sale, Cheshire, United Kingdom

St Mary's Hospital - PPDS
London, City Of London, United Kingdom

Royal Free Hospital
London, United Kingdom

GatesMRI, Study Director
Bill & Melinda Gates Medical Research Institute

Bill & Melinda Gates Medical Research Institute
NCT Number
Keywords
rivaroxaban
Xarelto
Coronavirus
Covid-19
Coronavirus disease 2019
MeSH Terms
COVID-19
Rivaroxaban